IL-2

Phase 2Small molecule

FFate Therapeutics

IL-2 is one of 665 small molecule programs targeting Rheumatic Disease. It is currently in Phase 2.

Indications

Total Trials

Active Trials

664

Competitors

Pipeline

Status by Indication[3][1]

Indication

Rheumatic DiseaseActive, not recruiting

Kidney CancerActive, not recruiting

LymphomaActive, not recruiting

LeukemiaActive, not recruiting

Metastatic MelanomaActive, not recruiting

NeuroblastomaActive, not recruiting

Cervical CarcinomaActive, not recruiting

Autoimmune DiseaseActive, not recruiting

Myelodysplastic SyndromeActive, not recruiting

MemoryActive, not recruiting

Rheumatic DiseasePreclinical

Active, not recruiting

Kidney CancerPhase 2

Active, not recruiting

LymphomaPhase 2

Active, not recruiting

LeukemiaPhase 2

Active, not recruiting

Metastatic MelanomaPhase 2

Active, not recruiting

NeuroblastomaPhase 1/Phase 2

Active, not recruiting

Cervical CarcinomaPhase 1/Phase 2

Active, not recruiting

Autoimmune DiseasePhase 1

Active, not recruiting

Myelodysplastic SyndromePhase 1/Phase 2

Active, not recruiting

MemoryPhase 1/Phase 2

Active, not recruiting

Showing 10 of 23 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Tecentriq

Roche

Preclinical

36 2

Trodelvy

Gilead

Preclinical

37 3

Halaven

Eisai

Preclinical

38 4

Tykerb

GSK

Preclinical

80 5

IL-2

FFate Therapeutics

Phase 2

1 6

Adriamycin

GGynecologic Oncology Group

Preclinical

87 7

Avastin

BBio-Thera Solutions

Preclinical

153 8

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 9

Prolia

Amgen

Preclinical

14 10

Gemzar

GGynecologic Oncology Group

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 3Active, not recruiting

Non-Small Cell Lung Cancer

NCT04596033

Q4 2026

Phase 1Recruiting

Advanced Solid Tumors

NCT05881525

Q2 2027

Phase 1Recruiting

B-Cell Acute Lymphoblastic Leukemia

NCT03666000

Q3 2027

Phase 1Not yet recruiting

Advanced NSCLC

NCT07105176

Clinical

Trials by Indication[1]

Advanced Solid Tumors7 trials

Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors

Recruiting·GGuangzhou FineImmune Biotechnology Co., LTD.·Phase 1·NCT06302062·23 enrolled

FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors

Terminated·FFate Therapeutics·Phase 1·NCT05395052·5 enrolled

NY-ESO-1 TCR-T Cells for NY-ESO-1 Positive Subjects With Advanced Solid Tumors

Recruiting·TTCRCure Biopharma Ltd.·Phase 1·NCT05881525·18 enrolled

Show 4 more trials

TIL Cells for the Treatment of the Advanced Solid Tumors Patients

Not yet recruiting·FFujian Cancer Hospital·Phase 1·NCT05649618·42 enrolled

TCR-T Cells for the Treatment NY-ESO-1-positive Advanced Solid Tumors

Not yet recruiting·FFujian Cancer Hospital·Phase 1·NCT05648994·30 enrolled

PRaG Regimens Rechallenge for Patients With Resistance to PD1/PD-L1 Inhibitors in Refractory Advanced Solid Tumors.

Unknown status·SSecond Affiliated Hospital of Soochow University·Phase 2·NCT05530200·56 enrolled

FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

Terminated·FFate Therapeutics·Phase 1·NCT04551885·12 enrolled

Renal Cell Carcinoma6 trials

Trial of G250 Peptide and IL-2 Following Surgical Resection of Locally Advanced/Metastatic Renal Cell Carcinoma

Terminated·UUniversity of Chicago·Phase 2·NCT00203866·40 enrolled

PD-1 Knockout Engineered T Cells for Metastatic Renal Cell Carcinoma.

Withdrawn·PPeking University·Phase 1·NCT02867332

Study Comparing Association Between Sorafenib and Interleukin-2 (IL-2) Versus Sorafenib in 1st Line Therapy in Advanced (Adv) Renal Cell Carcinoma (RCC)

Completed·IItalian Trial in Medical Oncology·Phase 2·NCT00609401·90 enrolled

Show 3 more trials

Bevacizumab, Autologous Tumor/DC Vaccine, IL-2 and IFNα-2b in Metastatic Renal Cell Carcinoma (RCC) Patients

Terminated·—·Phase 2·NCT00913913·8 enrolled

Study of Hydroxychloroquine and Aldesleukin in Renal Cell Carcinoma Patients (RCC)

Completed·LLeonard Appleman·Phase 1/2·NCT01550367·30 enrolled

Safety and Biological Activity of TroVax® Vaccine Given With IL-2 in Renal Cell Carcinoma

Completed·OOxford BioMedica·Phase 2·NCT00325507·25 enrolled

Treatment4 trials

Low Dose IL-2 in the Treatment of Immune-associated ALS Syndrome

Unknown status·PPeking University Third Hospital·Phase 2·NCT04952155·13 enrolled

The Incidence of Infection in Treatment of Low-dose IL-2 of SLE Patients

Unknown status·PPeking University People's Hospital··NCT04136106·500 enrolled

Study of Autologous Peripheral Blood Lymphocytes in the Treatment of Patients With CLL or SLL

Completed·IIovance Biotherapeutics, Inc.·Phase 1·NCT04155710·7 enrolled

Show 1 more trial

Effect of Intermittent Aldesleukin Treatment With or Without Anti-HIV Drugs in HIV Infected People

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00110812·267 enrolled

Melanoma4 trials

IL-2 "SELECT" Tissue Collection Protocol in Patients With Advanced Melanoma

Completed·—··NCT01288963·153 enrolled

A Clinical Study of the Safety and Activity of the Investigational Cell Therapy NEO-PTC-01 in Patients With Advanced Melanoma

Terminated·BBioNTech US Inc.·Phase 1·NCT04625205·22 enrolled

Vaccine Therapy and GM-CSF With or Without Low-Dose Aldesleukin in Treating Patients With Stage II, Stage III, or Stage IV Melanoma

Completed·MMayo Clinic·Phase 1·NCT00470015·20 enrolled

Show 1 more trial

Vaccine Treatment in Combination With IL-2 and Treated Lymphocytes for Advanced Melanoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00080353·58 enrolled

Metastatic Melanoma4 trials

Adoptive Cell Therapy Following a Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Melanoma Patients

Recruiting·SSheba Medical Center·Phase 2·NCT03166397·30 enrolled

Chemotherapy, Irradiation, Cell Infusions, and Interleukin-2 to Treat Metastatic Melanoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00314106·26 enrolled

Lymphocyte Re-infusion During Immune Suppression to Treat Metastatic Melanoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00001832·170 enrolled

Show 1 more trial

Immunization of Patients With Metastatic Melanoma Using the GP100 Peptide Preceded by an Endoplasmic Reticulum Insertion Signal Sequence

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00001705·141 enrolled

47 more indications

Leukemia3 trials

Lymphocytic B-Leukemia (B-CLL) w/Human IL-2 Gene Modified & Human CD40 Ligand-Expressing Autologous Tumor Cells

Withdrawn·—·Phase 1·NCT00224354

Safety of Expanded Haploidentical Natural Killer Cells for Leukemia

Completed·—·Phase 1·NCT04327037·10 enrolled

Haploidentical Natural Killer Cells to Treat Refractory or Relapsed Acute Myelogenous Leukemia (AML)

Terminated·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT01106950·15 enrolled

Lymphoma2 trials

A Pilot Study of Immunotherapy Including Haploidentical NK Cell Infusion Following CD133+ Positively-Selected Autologous Hematopoietic Stem Cells in Children With High Risk Solid Tumors or Lymphomas

Completed·SSt. Jude Children's Research Hospital·Phase 1·NCT02130869·8 enrolled

A Randomized Study of EPOCH II Versus EPOCH II and Immunotherapy in Lymphomas

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00001430·49 enrolled

Non-Small Cell Lung Cancer2 trials

Vinorelbine Metronomic Chemotherapy Combined With Hypofractionated Radiotherapy, PD-1/PD-L1 Sequential GM-CSF and IL-2 for Treatment of Advanced Refractory Non-small Cell Lung Cancer and Breast Cancer(PRaG 6.0)

Unknown status·SSecond Affiliated Hospital of Soochow University·Phase 2·NCT05603013·45 enrolled

LIBRETTO-531: Selpercatinib vs MKI in RET+ NSCLC

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 3·NCT04596033·261 enrolled

Acute Myeloid Leukemia2 trials

Natural Killer-cell Therapy for Acute Myeloid Leukemia

Terminated·RRadboud University Medical Center·Phase 1/2·NCT04347616·9 enrolled

NK Cells as Consolidation Therapy of Acute Myeloid Leukemia in Children/Adolescents

Completed·IInstituto de Investigación Hospital Universitario La Paz·Phase 2·NCT02763475·7 enrolled

Advanced2 trials

Adoptive Transfer of iNKT Cells for Treating Patients With Relapsed/Advanced HCC

Completed·—·Phase 1·NCT03175679·10 enrolled

Adoptive Transfer of Specific HCC Antigens CD8+ T Cells for Treating Patients With Relapsed/Advanced HCC

Unknown status·—·Phase 1·NCT03175705·18 enrolled

B-cell Malignancies2 trials

A Study of CNTY-101 in Participants With CD19-Positive B-Cell Malignancies

Terminated·CCentury Therapeutics, Inc.·Phase 1·NCT05336409·28 enrolled

FT819 in Subjects With B-cell Malignancies

Active, not recruiting·FFate Therapeutics·Phase 1·NCT04629729·54 enrolled

Ovarian Cancer2 trials

FT516 and IL2 With Enoblituzumab for Ovarian Cancer

Completed·MMasonic Cancer Center, University of Minnesota·Phase 1·NCT04630769·3 enrolled

OVSTAR TIL Trial (OVarian Cancer Co-STimulatory Antigen Receptor TIL Trial)

Withdrawn·IImmetacyte Ltd·Phase 1/2·NCT04389229

Kidney Cancer2 trials

Natural Killer Cells Plus IL-2 Following Chemotherapy to Treat Advanced Melanoma or Kidney Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00328861·8 enrolled

Cultured White Cells Plus Interleukin-2 to Treat Advanced Kidney Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT00091611·3 enrolled

Autoimmune Disease1 trial

A Study of CNTY-101 in Participants With Refractory B Cell-mediated Autoimmune Diseases

Active, not recruiting·CCentury Therapeutics, Inc.·Phase 1·NCT06255028·6 enrolled

Immunomodulation1 trial

Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in VCA

Terminated·—·Phase 1·NCT03241719·2 enrolled

Transplantation1 trial

A Pilot Study of Tumor-Specific Peptide Vaccination and IL-2 With or Without Autologous T Cell Transplantation in Recurrent Pediatric Sarcomas

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00001564·30 enrolled

Radiation Therapy1 trial

High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy for Metastatic Renal Cancer

Completed·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT01896271·30 enrolled

Rheumatic Disease1 trial

The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic Diseases

Completed·TThe First Hospital of Jilin University·N/A·NCT04397107·46 enrolled

Neuroblastoma1 trial

Activated T Cells Armed With GD2 Bispecific Antibody in Children and Young Adults With Neuroblastoma and Osteosarcoma

Unknown status·UUniversity of Virginia·Phase 1/2·NCT02173093·40 enrolled

B-cell acute lymphoblastic leukemia1 trial

Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

Recruiting·IImugene Limited·Phase 1·NCT03666000·135 enrolled

Advanced Refractory Solid Tumors1 trial

Hypofractionated Radiotherapy Combined With PD-1 Inhibitor Sequential GM-CSF and IL-2 for the Treatment of Advanced Refractory Solid Tumors (PRaG2.0)

Unknown status·SSecond Affiliated Hospital of Soochow University·Phase 2·NCT04892498·66 enrolled

Memory1 trial

Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML

Recruiting·WWashington University School of Medicine·Phase 1/2·NCT06158828·68 enrolled

Hematopoietic Stem Cell Transplantation1 trial

Low Dose IL-2, Hematopoietic Stem Cell Transplantation, IL2 for GVHD

Completed·—·Phase 2·NCT00539695·25 enrolled

First Line Therapy1 trial

Phase II Trial of FOLFOXIGIL Versus FOLFOXIRI as First-line Therapy in Patients With mCRC

Withdrawn·FFujian Cancer Hospital·Phase 2·NCT03222089

Primary Peritoneal Cancer1 trial

Intraperitoneal Natural Killer Cells and INCB024360 for Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Completed·MMasonic Cancer Center, University of Minnesota·Phase 1·NCT02118285·2 enrolled

Cell Therapy1 trial

Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Ovarian

Unknown status·SSheba Medical Center·Phase 2·NCT03412526·15 enrolled

Myelodysplastic Syndrome1 trial

Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Terminated·WWashington University School of Medicine·Phase 1/2·NCT01898793·89 enrolled

Henoch-Schönlein Purpura1 trial

The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 in Children With Henoch-schönlein Purpura

Completed·TThe First Hospital of Jilin University·N/A·NCT04387942·59 enrolled

Patients With Advanced Solid Tumors1 trial

TIL Therapy for Patients With Advanced Solid Tumors

Not yet recruiting·NNeogenTC·Phase 1·NCT06107894·12 enrolled

Immune Checkpoint Inhibitors1 trial

FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors

Completed·FFate Therapeutics·Phase 1·NCT03841110·37 enrolled

Withdrawn·PPeking University·Phase 1·NCT02863913

Pembrolizumab1 trial

UCDCC#272: IL-2, Radiotherapy, and Pembrolizumab in Patients Refractory to Checkpoint Blockade

Active, not recruiting·MMegan Daly, MD·Phase 1/2·NCT03474497·18 enrolled

Immune Response1 trial

MIROCALS: Modifying Immune Response and OutComes in ALS

Completed·—·Phase 2·NCT03039673·304 enrolled

Breast Cancer1 trial

Allogeneic Natural Killer (NK) Cells for Ovarian, Fallopian Tube, Peritoneal and Metastatic Breast Cancer

Completed·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT01105650·13 enrolled

Type 1 Diabetes1 trial

Proleukin and Rapamune in Type 1 Diabetes

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00525889·9 enrolled

Growth1 trial

Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer

Suspended·DDavid Wald·Phase 1·NCT05400122·12 enrolled

Mantle Cell Lymphoma1 trial

Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT00101101·43 enrolled

Patients With Solid Tumors1 trial

A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors

Suspended·PPACT Pharma, Inc.·Phase 1·NCT03970382·21 enrolled

Gene Therapy1 trial

T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT05035407·36 enrolled

Depressive Symptoms1 trial

Effectiveness of Escitalopram in Preventing or Reducing Depressive Symptoms in People Receiving Interleukin-2 Treatment

Completed·EEmory University·Phase 4·NCT00352885·20 enrolled

Lymphoid Malignancies1 trial

CD19-specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT00968760·34 enrolled

Systemic Therapy1 trial

Systemic Therapy With Interferon, Interleukin-2 and BRAF Inhibitor

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT01603212·6 enrolled

Interleukin1 trial

Immune Mobilization of Autologous Peripheral Blood Stem Cells Using Interleukin-2 and GM-CSF

Completed·—·Phase 1·NCT00952237·13 enrolled

Infection1 trial

HIV Immune and Virological Responses Following the Administration of IL-2 Either Alone or Combined to ALVAC-HIV 1433 and HIV Lipopeptides in Patients Treated Early With HAART During Primary Infection

Terminated·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 2·NCT00196651·60 enrolled

Advanced Hematologic Malignancies1 trial

FT516 in Subjects With Advanced Hematologic Malignancies

Terminated·FFate Therapeutics·Phase 1·NCT04023071·72 enrolled

Cervical Carcinoma1 trial

HPV16 E6 TCR T Cells for Cervical Carcinoma

Terminated·TTCRCure Biopharma Ltd.·Phase 1/2·NCT05357027·5 enrolled

Prostate Cancer1 trial

PD-1 Knockout Engineered T Cells for Castration Resistant Prostate Cancer

Withdrawn·PPeking University··NCT02867345

Advanced NSCLC1 trial

HS-IT101 Injection for Advanced NSCLC

Not yet recruiting·QQingdao Sino-Cell Biomedicine Co., Ltd.·Phase 1·NCT07105176·12 enrolled

Tolerance1 trial

Low-dose IL-2 for Treg Expansion and Tolerance (LITE)

Terminated·KKing's College London·Phase 4·NCT02949492·6 enrolled

Unresectable or Metastatic Melanoma1 trial

PICSTAT (PET Imaging of CD8 for Selection of Tumors for Autologous TIL): A Pilot Study Assessing the Use of CD8 PET/CT (Zr-89 Crefmirlimab Berdoxam) to Enhance Lifileucel (AMTAGVI) Efficacy in Patients With Treatment Refractory Stage IV Melanoma

Not yet recruiting·AAbramson Cancer Center at Penn Medicine·Phase 1·NCT07700121·10 enrolled

Sources

References

[1]
ClinicalTrials.gov — 81 trial records for IL-2. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — IL-2 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for IL-2. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Fate Therapeutics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: FFate Therapeutics

IL-2

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q2 2027

Q3 2027

Trials by Indication[1]

Advanced Solid Tumors7 trials

Renal Cell Carcinoma6 trials

Treatment4 trials

Melanoma4 trials

Metastatic Melanoma4 trials

Leukemia3 trials

Lymphoma2 trials

Non-Small Cell Lung Cancer2 trials

Acute Myeloid Leukemia2 trials

Advanced2 trials

B-cell Malignancies2 trials

Ovarian Cancer2 trials

Kidney Cancer2 trials

Autoimmune Disease1 trial

Immunomodulation1 trial

Transplantation1 trial

Radiation Therapy1 trial

Rheumatic Disease1 trial

Neuroblastoma1 trial

B-cell acute lymphoblastic leukemia1 trial

Advanced Refractory Solid Tumors1 trial

Memory1 trial

Hematopoietic Stem Cell Transplantation1 trial

First Line Therapy1 trial

Primary Peritoneal Cancer1 trial

Cell Therapy1 trial

Myelodysplastic Syndrome1 trial

Henoch-Schönlein Purpura1 trial

Patients With Advanced Solid Tumors1 trial

Immune Checkpoint Inhibitors1 trial

Graft Versus Host Disease1 trial

Metastatic Renal Cell Cancer1 trial

Bladder Cancer1 trial

Pembrolizumab1 trial

Immune Response1 trial

Breast Cancer1 trial

Type 1 Diabetes1 trial

Growth1 trial

Mantle Cell Lymphoma1 trial

Patients With Solid Tumors1 trial

Gene Therapy1 trial

Depressive Symptoms1 trial

Lymphoid Malignancies1 trial

Systemic Therapy1 trial

Interleukin1 trial

Infection1 trial

Advanced Hematologic Malignancies1 trial

Cervical Carcinoma1 trial

Prostate Cancer1 trial

Advanced NSCLC1 trial

Tolerance1 trial

Unresectable or Metastatic Melanoma1 trial

References

Drug Info

Quick Facts

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